Mifepristone Versus Laminaria Insertion for Cervical Preparation Prior to Surgical Abortion at 14-16 Weeks (SAMi)

This study has been completed.
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Lynn Borgatta, Boston University
ClinicalTrials.gov Identifier:
NCT00986921
First received: September 23, 2009
Last updated: December 28, 2013
Last verified: December 2013
  Purpose

Women who are requesting pregnancy termination at 14-16 weeks, who would normally have osmotic dilator insertion the day before their procedure, would be asked if they wanted to participate. Participants would be randomized to two groups: first, dilator insertion as usual, or second, mifepristone taken the day before the procedure.


Condition Intervention
Abortion
Drug: mifepristone 200 mg
Device: osmotic dilator insertion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mifepristone vs. Laminaria Insertion for Cervical Preparation Prior to Surgical Abortion at 14-16 Weeks

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • Time for Completion of Procedure [ Time Frame: Performance and completion of the abortion procedure takes 10-20 minutes. The length of the procedure is measured. The procedure occurs approximately 24 hours after enrollment. ] [ Designated as safety issue: No ]
    Minutes, from the time of the start of the procedure (speculum insertion) to the conclusion of the procedure (speculum removal)


Secondary Outcome Measures:
  • Assessment of Ease of Procedure by Operator [ Time Frame: It is administered shortly after the primary outcome, which is one day after enrollment. The study is complete at that point. ] [ Designated as safety issue: No ]
    The operator for each procedure rated the ease of procedure on a categorical scale. The categories were collapsed into two: "easy or very easy" and "average or difficult".

  • Moderate or Severe Pain Overnight [ Time Frame: Overnight ] [ Designated as safety issue: No ]
    Women wer asked to rank their amount of pain on a catergorical scale. The outcome measure is the number of women experiencing moderate or severe pain overnight (after mifepristone or osmotic dilators, and before the abortions procedure)


Enrollment: 50
Study Start Date: October 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: mifepristone
women in the mifepristone are would take mifepristone 200 mg for cervical preparation the day before their procedure, and not have dilators inserted. In this group, the sstandard procedure of osmotic dilator insertion is NOT performed.
Drug: mifepristone 200 mg
mifepristone would be given the day before the procedure
Active Comparator: Osmotic dilator insertion
Women assigned to this arm would have the standard procedure for cervical preparation, which is insertion of osmotic dilators the day before the abortion procedure
Device: osmotic dilator insertion
osmotic dilators (3-6) would be inserted as usual the day before the procedure

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women aged 18-45 having pregnancy termination at 14-16 weeks

Exclusion Criteria:

  • multiple gestation, pre-existing infection, contraindication to osmotic dilators, unable to obtain proper consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00986921

Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Society of Family Planning
Investigators
Principal Investigator: L B, MD, MPH Boston University
  More Information

No publications provided by Boston University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lynn Borgatta, Principal investigator, Boston University
ClinicalTrials.gov Identifier: NCT00986921     History of Changes
Other Study ID Numbers: SAMi
Study First Received: September 23, 2009
Results First Received: September 7, 2012
Last Updated: December 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Boston University:
Length of time for procedure to be completed
Need for additional dilation
Subject satisfaction with procedure

Additional relevant MeSH terms:
Mifepristone
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Abortifacient Agents, Steroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on April 17, 2014